Long-term follow-up of patients with lumbar spine disorders
Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.
This study looks at how well two different spinal surgery systems work for people with lumbar spine problems by checking their pain and disability levels over four years after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06933004 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the long-term clinical outcomes of patients who have undergone surgery for lumbar spine disorders. It monitors the effectiveness of two spinal fixation systems, the SmartMIS and ASA systems, through a series of questionnaire assessments. Patients will complete evaluations preoperatively and at multiple postoperative intervals to assess pain levels, disability, and fusion rates. The study aims to enroll 120 subjects over a duration of four years.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 80 with lumbar spine disorders requiring surgical intervention.
Not a fit: Patients who are unable to participate in follow-up assessments or have impaired decision-making capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of spinal fixation systems for patients with lumbar disease.
How similar studies have performed: While similar observational studies have been conducted, the specific focus on these spinal fixation systems in a long-term follow-up context may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 20 and 80 years. 2. Patients with lumbar spine disorders requiring surgical treatment. 3. Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form. Exclusion Criteria: 1. Individuals with impaired decision-making capacity or from vulnerable populations. 2. Individuals who are unable or unwilling to return for follow-up assessments.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Dr. Xiao Furen
- Email: fxiao@ntu.edu.tw
- Phone: +886 2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.